Intervention Media to Prevent Adolescent Cyber-conflict Through Technology (IMPACT)

September 20, 2021 updated by: Rhode Island Hospital
The purpose of this randomized pilot trial is to test the feasibility of online recruitment and intervention delivery of the same Intervention to Prevent Cyber-victimization among Adolescents through Text-Messaging (iPACT) intervention content, delivered via mobile app (instead of SMS). This study includes a brief remote introductory session, followed by eight weeks of daily, tailored two-way messages, with an 8-week assessment. If successful, the IMPACT intervention will demonstrate feasibility and acceptability of an easily disseminable intervention to improve wellness and resilience among at-risk youth and their social network.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cyber-bullying, defined as intentional harm of others through computers, cellphones, and other electronic devices, is increasingly common. Approximately one quarter of American adolescents report that they have been cyber-victims in the past year (with rates ranging from 6-72%, depending on the study). Being a victim of cyber-bullying is strongly associated with multiple negative consequences. Cyber-victimization predicts depressive symptoms and suicidality; it correlates with Post Traumatic Stress Disorder (PTSD) symptoms, alcohol and other drug use, physical peer violence, and dating violence. Emotional regulation skills and positive social supports may be protective. Development of an acceptable, effective, and potentially disseminable secondary prevention tool, to decrease both the frequency and consequences of cyber-victimization, is therefore of high public health importance.

Effective, acceptable, and easily disseminable secondary prevention tools are needed to improve adolescent resilience and reduce the negative effects of cybervictimization. Ninety-five percent of adolescents have access to a smartphone. Our team recently conducted an NICHD-funded pilot of an in-person brief intervention + automated 8-week interactive text-message program ("iPACT"), to reduce cyber-victimization among youth recruited in a pediatric clinic. Pilot testing of iPACT showed high acceptability (89% responses to daily messages), and preliminary signals of efficacy (e.g. improved use of bystander behaviors). However, our team identified two elements for improvement. First, the in-person brief intervention was difficult to deliver during a clinic visit due to patients' time limitations. Second, our and others' work suggests that at-risk youth are more commonly witnesses of cyber-victimization, than victims themselves, and therefore need greater content focused on bystander intervention. Third, at-risk youth may be more easily identified online than in person.

Participants will be identified through targeted Instagram advertisements. If eligible, participants will complete an online assent form followed by a series of comprehensive questions to assess for capacity to assent. Participants will complete a baseline assessment and will be randomized to experimental (IMPACT, n=40) or connection to Enhance Online Resources (EOR, n=40).

This study will pilot an enhanced intervention, "IMPACT" is a two-part remotely-delivered intervention for youth reporting online victimization, derived from iPACT's existing structure, to promote pro-social behavior and enhance wellness among at-risk adolescents. We will deliver a brief, computer-guided discussion (an adaptation of iPACT's in-person intervention) remotely via video chat; and deliver 8 weeks of automated, enhanced message content that helps participants identify, intervene in, and effectively reduce the impact of witnessed or experienced cyberbullying. EOR group participants will receive standardized information on cyberbullying.

Participants will complete assessments at baseline, 8 weeks, and 16 week to measure cyberbullying, peer violence, and cognitive/behavioral skill sets. At the 8 week follow-up, we will assess for efficacy, acceptability, usability, and feasibility through standardized qualitative and quantitative measures.

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • reside in the US
  • being English-speaking
  • having a English-speaking parent
  • active Instagram account
  • self-reporting cyber-victimization (defined as endorsing >1 past-year episode of technology mediated victimization)

Exclusion Criteria:

  • being cognitively unable to take part in the intervention as determined by study staff

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: IMPACT Intervention
  1. Remote brief video session, introducing basic principles of cognitive behavioral theory and the structure of the mobile application message portion of the intervention.
  2. Eight-weeks longitudinal tailored Cognitive Behavioral Therapy (CBT)-based messaging program
Behavioral: IMPACT Intervention
Brief remote session + tailored, daily 8-week mobile application facilitated messaging secondary prevention intervention.
ACTIVE_COMPARATOR: Control Enhanced Online Resources (EOR)
1. We will provide a link to an online resource packet with information on bullying and mental health resources.
Other: Control: Enhanced Online Resources (EOR)
EOR group participants will receive standardized information on cyberbullying.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention Acceptability: Enrollment Rate
Time Frame: Baseline
% of eligible participants who consented and completed enrollment
Baseline
Intervention Acceptability: Participant Satisfaction
Time Frame: 8 week post-enrollment
% of participants that agree or strongly agree on the quantitative acceptability assessment and qualitative interviews
8 week post-enrollment
Intervention Feasibility: Participant Engagement
Time Frame: Baseline to 8 weeks post-enrollment (close of intervention)
% of intervention participants that complete study components including responding to at least one of the daily message queries, and how many requested on-demand support messages
Baseline to 8 weeks post-enrollment (close of intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cyber-victimization and related online behaviors
Time Frame: Baseline, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment
Change in University of New Hampshire Internet Safety Education Survey (UNH) from enrollment other forms (cyberbullying); investigators selected 5 items from the survey to measure. Items are scored by participants' self-report of online harassment experiences ranging from 0 ("Never") to 4 ("7 or more times"). Possible score range of 0-20, with higher scores indicating greater number of online harassment experiences.
Baseline, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment
Psychological stress
Time Frame: Baseline, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment
Change in Patient-Reported Outcomes Measurement Information System (PROMIS); Four items are scored by participants' self-report of Psychological Stress ranging from 1 ("Never") to 5 ("Always"). The raw score ranges from 4 to 20, 4 representing least and 20 representing most psychological stress.
Baseline, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment
Positive affect
Time Frame: Baseline, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment
Change in Patient-Reported Outcomes Measurement Information System (PROMIS); Four items are scored by participants' self-report of Positive Affect ranging from 1 ("Never") to 5 ("Always"). The raw score ranges from 4 to 20, 4 representing least and 20 representing most positive affect.
Baseline, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment
Well-being Index
Time Frame: Baseline, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment
The World Health Organization- Five- Well-Being Index (WHO-5 ) from enrollment other forms (well-being); Five items are scored by participants' self-report of well-being ranging from 0 ("At no time") to 5 ("All of the time"). The raw score ranges from 0 to 25, 0 representing worst possible and 25 representing best possible quality of life.
Baseline, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment
Theoretical mechanisms of prosocial behaviors and self-efficacy
Time Frame: Baseline, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment
Change in Bystander Intervention in Bullying Measures; 5 items from the Bystander Intervention in Bullying Measures and 8 items from the University of New Hampshire Internet Safety Education Survey. Items are scored by participants' self-report of online bystander behavior ranging from 1 ("Strongly disagree") to 5 ("Strongly agree"). Possible score range of 13-65, with higher scores indicating greater personal responsibility/self-efficacy to intervene when witnessing online harassment experiences (prosocial behavior and self-efficacy).
Baseline, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rhode Island Hospital

Collaborators

University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 30, 2020

Primary Completion (ACTUAL)

May 3, 2020

Study Completion (ACTUAL)

June 30, 2020

Study Registration Dates

First Submitted

January 30, 2020

First Submitted That Met QC Criteria

February 4, 2020

First Posted (ACTUAL)

February 6, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 21, 2021

Last Update Submitted That Met QC Criteria

September 20, 2021

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0000000136/132580194 (OTHER_GRANT: University of Wisconsin Madison/PIVOTAL)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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